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M-protein interference in laboratory diagnostics: a comprehensive narrative review of mechanisms and management

Shanshan Liang1,2, Xinyu Wang1,2, Lin Peng3

  • 1Department of the Laboratory Medicine, West China Hospital, Sichuan University, Chengdu, China.

Clinical Chemistry and Laboratory Medicine
|May 11, 2026
PubMed

Insights

Monoclonal proteins (M-proteins) and therapeutic monoclonal antibodies (t-mAbs) can interfere with laboratory tests, leading to inaccurate diagnoses. This review covers interference mechanisms and mitigation strategies for improved patient safety.

Area of Science:

  • Clinical Diagnostics
  • Biochemistry
  • Immunology

Background:

  • Monoclonal proteins (M-proteins) are key biomarkers for plasma cell dyscrasias.
  • M-proteins cause diagnostic interferences across various laboratory platforms.
  • Therapeutic monoclonal antibodies (t-mAbs) create "drug spikes" that mimic disease markers.

Purpose of the Study:

  • To elucidate the mechanisms of M-protein and t-mAb interference in laboratory diagnostics.
  • To review current and emerging strategies for mitigating these analytical artifacts.
  • To provide a framework for recognizing and resolving diagnostic interferences.

Main Methods:

  • Narrative review synthesizing evidence from clinical cohorts and technical evaluations.
  • Analysis of interference mechanisms including precipitation, chemical binding, and hook effects.
  • Assessment of mitigation strategies from traditional to next-generation solutions.

Main Results:

  • M-protein interference affects electrophoresis, coagulation, clinical chemistry, and immunoassays.
  • t-mAbs introduce exogenous spikes, complicating disease monitoring.
  • Various mitigation techniques, including mass spectrometry and AI, show promise.

Conclusions:

  • M-protein and t-mAb interferences pose significant challenges to accurate laboratory diagnostics.
  • Effective recognition and resolution of these artifacts are crucial for patient safety.
  • Advancements in technology offer improved strategies for managing diagnostic interferences.
Keywords:
M-proteinassay interferencelaboratory test interferencemass spectrometrymitigation strategiestherapeutic monoclonal antibodies

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